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临床试验/NCT04503785
NCT04503785招募中不适用

Esophageal Impedance and Manometry Measurements and Dysphagia Symptom Scoring

Indiana University2 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2017年1月17日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
1,000
试验地点
2
主要终点
Endoflip parameters for gastroparesis

研究概览

简要总结

Comparison of manometry measurements and EndoFlip Balloon measurements in patients with dysphagia and a known esophageal diagnosis

详细描述

Gastrointestinal (GI) motility problems are very common in the general population. Dysphagia, difficulty swallowing, is one of the most common issues in gastroenterology. In many patients, esophageal obstruction is not identified despite workup with upper endoscopy or barium swallow x-ray. Patients are often referred to the Motility Laboratory for evaluation of non-obstructive dysphagia. Transnasal esophageal manometry-impedance is a diagnostic test to measure the pressures and coordination of the esophagus during swallowing. The Endolumenal Functional Lumen Imaging Probe (EndoFLIP) is another instrument used to measure the lumen distensibility of the esophagus and pylorus. Both tests are FDA-approved and are currently being used in clinical practice. However, correlation of the results obtained from these tests with clinical syndromes and symptoms is not clearly understood. Furthermore, the relationship between esophageal impedance-manometry and EndoFLIP results has never been defined.

The primary Aim is to develop a registry of patients undergoing esophageal manometry-impedance and Endoflip from the GI Motility Lab at the IU University Hospital

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All patients who presented to GI Motility Lab at IU University Hospital for esophageal manometry-impedance and/or EndoFLIP

排除标准

  • Age <18 yrs old
  • Unable to communicate verbally with the staff

研究组 & 干预措施

Dysphagia

Patients with Esophageal dysphagia

干预措施: Manometry (Diagnostic Test)

结局指标

主要结局

Endoflip parameters for gastroparesis

时间窗: 5 years

Compare the distensibility index (mm2/mmHg) of the pylorus at 50 ml distension in patients with postsurgical gastroparesis and compare to patients with idiopathic and diabetic gastroparesis.

次要结局

  • Correlation between endoflip parameters and gastric scintigraphy(5 years)
  • Correlation between endoflip parameters and symptom severity(5 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

John M. Wo

Director of Motility and Neurogastroenterology Unit

Indiana University

研究点 (2)

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